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Job Reference Number


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Posted On:

May 3 2012



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The Validation Engineer is a member of the Product Transfer team, playing a key role in the planning and execution of validation activities related to project. Provide support for the validation activities associated with equipment & processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed.


  • Continuous Improvement Focus
  • Conduct validation activities in compliance with US and EU relations, GBSC procedures and EHS requirements
  • Participate in the design of systems and equipment to ensure that they comply with GMP requirements
  • Develop validation documentation as required (e.g. specifications, plans, protocols, procedures)
  • Develop pFMEA documentation to support processes as part of Validation process
  • Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls)
  • Execute qualification protocols as requiredCompile relevant documentation from contractors, suppliers and other departments for inclusion in reports
  • Generation/Modification of Process Specifications as required
  • Prepare reports of executed protocols for review by QA
  • Initiate and implement change control activities in accordance with site procedures
  • Track and resolve exceptions during qualification activities
  • Prioritize qualification activities in line with the project schedule
  • Coordinate qualification activities with engineering, construction and commissioning activities
  • Coordinate qualification activities with contractors and vendors as required
  • Coordinate qualification document review and approval
  • Collate and organise qualification files for turnover to QADC
  • Attend identified training, required to fulfil the role of Validation Engineer
  • Assist in the development of training material for qualification activities
  • Participate in cross-functional teams as required
  • Deputises for the QA Validation Manager when designated as appropriate
  • Domestic and international travel may be required.


  • Degree Quality/Manufacturing/Engineering
  • Minimum of 3-5yrs experience in Quality Assurance/Engineering (a minimum of 2yrs of which has been spent carrying out validations
  • Experience in generation of pFMEA
  • Ability to analyse Capability data using MINITAB
  • Ability to interpret Engineering drawings/specifications
  • Familiarity in areas of various inspection techniques
  • Excellent interpersonal & communication skills
  • In depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry
  • High understanding of GMP, Compliance, Validation practices including the system development life cycle and regulatory expectations
  • Working knowledge of Quality systems (FDA/ISO) within a regulated environment

If this position is of interest, please forward your CV to Fastnet Recruitment or telephone Jill for a confidential discussion at 021 4554061.

[email protected] Fastnet Recruitment has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet Recruitment 'Not Just Placers.........Partners'


The Pharmaceutical Recruitment Specialists